This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for the model 6996 sq lead system and the 6996t tunneling tool. The model 6996 sq lead system is for single, long-term subcutaneous use and is intended for use in patients in which implantable cardioverter defibrillators (icd) are indicated. The lead is intended for use if a standard icd system with one or two transvenous leads has not been efficacious in providing acceptable dft measurements. The model 6996 sq lead is intended for use only with the following systems: a medtronic icd featuring a connector block with at least two df-1 connector ports; and a medtronic right ventricular lead for defibrillating/pacing/sensing. In addition, a third defibrillation lead, such as any medtronic svc lead, may be used with a lead adaptor.
| Device | MODEL 6996 SQ LEAD SYSTEM AND 6996T TUNNELING TOOL |
| Classification Name | Implantable Cardioverter Defibrillator (non-crt) |
| Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2001-02-05 |
| Decision Date | 2001-06-11 |
| PMA | P920015 |
| Supplement | S021 |
| Product Code | LWS |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC Inc. 8200 Coral Sea Street Ne ms Mv S11 mounds View, MN 55112 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P920015 | Original Filing | |
| S274 | 2023-01-09 | 30-day Notice |
| S273 | 2022-11-16 | 30-day Notice |
| S272 | 2022-10-19 | 30-day Notice |
| S271 | 2022-09-13 | 30-day Notice |
| S270 | 2022-06-17 | Normal 180 Day Track No User Fee |
| S269 | 2022-05-20 | 30-day Notice |
| S268 | 2022-04-27 | 30-day Notice |
| S267 | 2022-04-14 | 30-day Notice |
| S266 | 2022-02-23 | 30-day Notice |
| S265 | 2022-02-10 | 30-day Notice |
| S264 | 2022-01-13 | 30-day Notice |
| S263 | 2021-11-24 | 30-day Notice |
| S262 | 2021-11-19 | 30-day Notice |
| S261 | 2021-11-18 | 30-day Notice |
| S260 | 2021-11-03 | 30-day Notice |
| S259 | 2021-08-09 | 30-day Notice |
| S258 | 2021-08-04 | 30-day Notice |
| S257 | 2021-07-29 | 30-day Notice |
| S256 | ||
| S255 | 2021-06-15 | 30-day Notice |
| S254 | 2021-03-19 | 30-day Notice |
| S253 | 2021-02-05 | 30-day Notice |
| S252 | 2020-12-07 | Real-time Process |
| S251 | 2020-12-07 | 30-day Notice |
| S250 | 2020-12-01 | 30-day Notice |
| S249 | ||
| S248 | 2020-11-18 | 30-day Notice |
| S247 | 2020-10-23 | 30-day Notice |
| S246 | 2020-09-17 | 30-day Notice |
| S245 | 2020-07-09 | 30-day Notice |
| S244 | 2020-06-26 | 30-day Notice |
| S243 | 2020-03-23 | Real-time Process |
| S242 | 2020-02-20 | 30-day Notice |
| S241 | 2020-01-27 | 30-day Notice |
| S240 | 2019-12-17 | 30-day Notice |
| S239 | 2019-11-18 | 30-day Notice |
| S238 | 2019-11-13 | 30-day Notice |
| S237 | 2019-11-12 | 30-day Notice |
| S236 | 2019-09-16 | 30-day Notice |
| S235 | 2019-07-01 | 30-day Notice |
| S234 | ||
| S233 | 2019-06-20 | 30-day Notice |
| S232 | 2019-06-10 | 30-day Notice |
| S231 | 2019-05-31 | 30-day Notice |
| S230 | 2019-05-20 | 30-day Notice |
| S229 | 2019-05-02 | Normal 180 Day Track No User Fee |
| S228 | 2019-04-05 | 30-day Notice |
| S227 | 2019-03-04 | 30-day Notice |
| S226 | 2019-02-28 | 30-day Notice |
| S225 | 2019-01-30 | Normal 180 Day Track No User Fee |
| S224 | 2018-11-21 | 30-day Notice |
| S223 | 2018-11-02 | 30-day Notice |
| S222 | ||
| S221 | 2018-10-23 | 30-day Notice |
| S220 | 2018-10-18 | 30-day Notice |
| S219 | 2018-10-11 | 30-day Notice |
| S218 | 2018-09-26 | 30-day Notice |
| S217 | 2018-06-25 | Real-time Process |
| S216 | 2018-06-20 | 30-day Notice |
| S215 | 2018-06-01 | 30-day Notice |
| S214 | 2018-05-15 | 30-day Notice |
| S213 | 2018-04-13 | Normal 180 Day Track |
| S212 | 2018-04-09 | 30-day Notice |
| S211 | 2018-04-06 | 30-day Notice |
| S210 | 2018-03-28 | 30-day Notice |
| S209 | 2018-02-26 | 30-day Notice |
| S208 | 2018-02-22 | 30-day Notice |
| S207 | 2018-02-22 | 30-day Notice |
| S206 | 2018-02-12 | Real-time Process |
| S205 | 2017-12-21 | 30-day Notice |
| S204 | 2017-12-04 | Real-time Process |
| S203 | 2017-11-20 | 30-day Notice |
| S202 | 2017-08-09 | 30-day Notice |
| S201 | 2017-08-07 | 30-day Notice |
| S200 | 2017-06-28 | 30-day Notice |
| S199 | 2017-06-23 | 30-day Notice |
| S198 | 2017-06-07 | 30-day Notice |
| S197 | 2017-05-12 | 30-day Notice |
| S196 | 2017-01-25 | Real-time Process |
| S195 | 2017-01-17 | 30-day Notice |
| S194 | 2017-01-06 | 30-day Notice |
| S193 | 2016-12-23 | 30-day Notice |
| S192 | 2016-12-22 | 30-day Notice |
| S191 | 2016-12-06 | Normal 180 Day Track |
| S190 | 2016-11-28 | 30-day Notice |
| S189 | 2016-11-14 | 30-day Notice |
| S188 | 2016-11-02 | Normal 180 Day Track |
| S187 | 2016-10-25 | 30-day Notice |
| S186 | 2016-10-05 | 30-day Notice |
| S185 | 2016-09-22 | 30-day Notice |
| S184 | 2016-09-12 | 30-day Notice |
| S183 | 2016-09-02 | 30-day Notice |
| S182 | 2016-08-25 | 30-day Notice |
| S181 | 2016-06-24 | 30-day Notice |
| S180 | 2016-05-27 | 30-day Notice |
| S179 | 2016-05-03 | Normal 180 Day Track |
| S178 | 2016-04-15 | Normal 180 Day Track |
| S177 | 2016-03-11 | Normal 180 Day Track |
| S176 | 2016-03-08 | 30-day Notice |
| S175 | 2016-03-01 | Normal 180 Day Track |
| S174 | 2016-02-17 | 30-day Notice |
| S173 | 2016-01-14 | 30-day Notice |
| S172 | 2016-01-11 | 30-day Notice |
| S171 | 2016-01-07 | 30-day Notice |
| S170 | 2015-12-28 | 30-day Notice |
| S169 | 2015-12-22 | 30-day Notice |
| S168 | 2015-10-30 | Real-time Process |
| S167 | 2015-10-23 | 30-day Notice |
| S166 | 2015-10-13 | Normal 180 Day Track |
| S165 | 2015-09-30 | 30-day Notice |
| S164 | 2015-09-30 | Normal 180 Day Track |
| S163 | 2015-09-24 | Normal 180 Day Track |
| S162 | 2015-09-10 | 30-day Notice |
| S161 | 2015-07-14 | 30-day Notice |
| S160 | 2015-07-06 | 30-day Notice |
| S159 | 2015-07-02 | Real-time Process |
| S158 | 2015-06-25 | 30-day Notice |
| S157 | 2015-06-18 | 30-day Notice |
| S156 | 2015-06-08 | 30-day Notice |
| S155 | 2015-05-28 | Normal 180 Day Track |
| S154 | ||
| S153 | 2015-04-17 | 30-day Notice |
| S152 | 2015-04-14 | Real-time Process |
| S151 | 2015-03-16 | Normal 180 Day Track |
| S150 | 2015-03-12 | 30-day Notice |
| S149 | 2015-02-09 | 30-day Notice |
| S148 | 2015-02-09 | 30-day Notice |
| S147 | 2015-01-21 | 30-day Notice |
| S146 | 2014-12-22 | Normal 180 Day Track |
| S145 | 2014-10-15 | 30-day Notice |
| S144 | 2014-09-29 | 30-day Notice |
| S143 | 2014-09-15 | 30-day Notice |
| S142 | 2014-09-15 | 30-day Notice |
| S141 | 2014-09-05 | 30-day Notice |
| S140 | 2014-08-27 | 30-day Notice |
| S139 | 2014-08-13 | 30-day Notice |
| S138 | 2014-08-08 | 30-day Notice |
| S137 | 2014-07-28 | 30-day Notice |
| S136 | 2014-07-24 | 30-day Notice |
| S135 | 2014-07-14 | 30-day Notice |
| S134 | 2014-07-09 | 30-day Notice |
| S133 | 2014-07-02 | Real-time Process |
| S132 | 2014-06-16 | 30-day Notice |
| S131 | 2014-02-27 | 30-day Notice |
| S130 | ||
| S129 | 2014-01-29 | 30-day Notice |
| S128 | 2013-12-24 | 30-day Notice |
| S127 | 2013-12-19 | 30-day Notice |
| S126 | 2013-12-17 | 30-day Notice |
| S125 | 2013-11-27 | 30-day Notice |
| S124 | 2013-11-22 | 30-day Notice |
| S123 | 2013-10-30 | 30-day Notice |
| S122 | 2013-10-24 | Real-time Process |
| S121 | 2013-10-24 | 30-day Notice |
| S120 | 2013-09-30 | 30-day Notice |
| S119 | 2013-09-30 | 30-day Notice |
| S118 | 2013-09-17 | 30-day Notice |
| S117 | 2013-09-13 | Normal 180 Day Track No User Fee |
| S116 | 2013-09-13 | 30-day Notice |
| S115 | ||
| S114 | 2013-07-26 | 30-day Notice |
| S113 | 2013-05-17 | Real-time Process |
| S112 | ||
| S111 | 2013-04-30 | 30-day Notice |
| S110 | ||
| S109 | 2013-04-10 | Normal 180 Day Track No User Fee |
| S108 | 2013-04-08 | 135 Review Track For 30-day Notice |
| S107 | 2013-03-22 | 30-day Notice |
| S106 | 2013-03-21 | 30-day Notice |
| S105 | 2013-03-20 | 30-day Notice |
| S104 | 2012-12-21 | 30-day Notice |
| S103 | 2012-12-18 | 30-day Notice |
| S102 | 2012-12-10 | 30-day Notice |
| S101 | 2012-11-29 | 30-day Notice |
| S100 | 2012-11-21 | 30-day Notice |
| S099 | 2012-10-31 | Real-time Process |
| S098 | 2012-10-26 | Real-time Process |
| S097 | 2012-09-28 | 30-day Notice |
| S096 | 2012-09-21 | 30-day Notice |
| S095 | 2012-09-04 | 30-day Notice |
| S094 | 2012-08-03 | 30-day Notice |
| S093 | 2012-07-02 | Normal 180 Day Track |
| S092 | 2012-06-11 | 30-day Notice |
| S091 | 2012-05-23 | Real-time Process |
| S090 | 2012-03-26 | Real-time Process |
| S089 | 2012-03-07 | 30-day Notice |
| S088 | 2012-02-29 | 30-day Notice |
| S087 | 2012-02-27 | 30-day Notice |
| S086 | 2012-02-23 | 30-day Notice |
| S085 | 2011-11-25 | 30-day Notice |
| S084 | 2011-11-21 | Normal 180 Day Track |
| S083 | 2011-10-24 | 135 Review Track For 30-day Notice |
| S082 | 2011-07-18 | 30-day Notice |
| S081 | 2011-07-08 | 30-day Notice |
| S080 | 2011-06-28 | 30-day Notice |
| S079 | 2011-06-08 | 30-day Notice |
| S078 | 2011-06-08 | 135 Review Track For 30-day Notice |
| S077 | 2011-05-13 | 30-day Notice |
| S076 | 2011-04-26 | 30-day Notice |
| S075 | 2011-04-12 | 30-day Notice |
| S074 | 2011-03-22 | 135 Review Track For 30-day Notice |
| S073 | 2011-02-28 | 30-day Notice |
| S072 | 2010-12-10 | 30-day Notice |
| S071 | 2010-11-12 | 30-day Notice |
| S070 | 2010-10-26 | 30-day Notice |
| S069 | 2010-10-22 | Special (immediate Track) |
| S068 | 2010-10-14 | 30-day Notice |
| S067 | 2010-09-29 | 30-day Notice |
| S066 | ||
| S065 | 2010-07-15 | 30-day Notice |
| S064 | 2010-07-15 | 30-day Notice |
| S063 | 2010-07-15 | 30-day Notice |
| S062 | 2010-07-06 | 30-day Notice |
| S061 | 2010-06-28 | 135 Review Track For 30-day Notice |
| S060 | ||
| S059 | 2010-03-29 | 30-day Notice |
| S058 | 2010-01-19 | 30-day Notice |
| S057 | 2010-01-15 | Real-time Process |
| S056 | 2009-12-16 | Normal 180 Day Track No User Fee |
| S055 | 2009-12-04 | Normal 180 Day Track |
| S054 | 2009-03-26 | Normal 180 Day Track No User Fee |
| S053 | 2009-03-17 | Real-time Process |
| S052 | 2009-02-05 | 30-day Notice |
| S051 | 2008-12-11 | 30-day Notice |
| S050 | 2008-11-03 | 30-day Notice |
| S049 | 2008-10-27 | 30-day Notice |
| S048 | ||
| S047 | 2008-07-09 | 30-day Notice |
| S046 | 2008-06-17 | 30-day Notice |
| S045 | 2008-06-13 | 135 Review Track For 30-day Notice |
| S044 | 2008-04-14 | 30-day Notice |
| S043 | 2008-04-01 | 30-day Notice |
| S042 | 2008-03-31 | 30-day Notice |
| S041 | 2008-03-24 | 30-day Notice |
| S040 | 2008-03-10 | 135 Review Track For 30-day Notice |
| S039 | 2008-03-03 | Real-time Process |
| S038 | 2007-09-12 | 135 Review Track For 30-day Notice |
| S037 | 2007-05-15 | Real-time Process |
| S036 | 2006-11-20 | 30-day Notice |
| S035 | 2006-05-10 | 135 Review Track For 30-day Notice |
| S034 | ||
| S033 | ||
| S032 | 2005-09-02 | 135 Review Track For 30-day Notice |
| S031 | 2004-09-10 | Normal 180 Day Track |
| S030 | 2003-12-22 | Normal 180 Day Track |
| S029 | 2003-11-06 | Normal 180 Day Track |
| S028 | 2003-04-28 | Real-time Process |
| S027 | 2003-03-04 | 30-day Notice |
| S026 | ||
| S025 | 2001-11-05 | Special (immediate Track) |
| S024 | 2001-10-01 | Real-time Process |
| S023 | 2001-07-17 | 30-day Notice |
| S022 | 2001-05-31 | Real-time Process |
| S021 | 2001-02-05 | Normal 180 Day Track |
| S020 | 2000-11-13 | Real-time Process |
| S019 | ||
| S018 | ||
| S017 | 2000-06-20 | Normal 180 Day Track |
| S016 | 1999-08-12 | Special (immediate Track) |
| S015 | 1998-09-28 | Normal 180 Day Track |
| S014 | 1998-04-20 | |
| S013 | 1997-07-21 | Normal 180 Day Track |
| S012 | 1997-03-18 | Normal 180 Day Track |
| S011 | 1996-05-20 | Normal 180 Day Track |
| S010 | 1996-05-17 | Normal 180 Day Track |
| S009 | 1996-02-05 | Normal 180 Day Track |
| S008 | 1995-08-10 | Normal 180 Day Track |
| S007 | 1995-08-07 | Normal 180 Day Track |
| S006 | 1995-07-18 | Normal 180 Day Track |
| S005 | 1995-06-29 | Normal 180 Day Track |
| S004 | 1995-01-20 | Normal 180 Day Track |
| S003 | 1994-04-25 | Normal 180 Day Track |
| S002 | 1994-03-25 | Normal 180 Day Track |
| S001 | 1994-03-03 | Normal 180 Day Track |